NCT05299593

24-hour Efficacy and Tolerability of the Tafluprost-timolol Fixed Association Without Preservatives in Glaucomatous or Ocular Hypertensive Patients Already Treated With Latanoprost Preserved With BAK. A Prospective, Open Study of 3 Months Duration.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Fondazione G.B. Bietti, IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase IV, interventional, multi-center, open clinical Trial. Patients will be administered one eye drop of tafluprost/timolol fixed combination at 20:00 (+/- 1 hour), in the treatment of open angle glaucoma and ocular hypertension. The patients will suspend the treatment with latanoprost.

Detailed description

This is a phase IV, interventional, multi-center, not comparative, open clinical Trial to evaluate the effectiveness in reducing the mean 24-hour IOP of the preservative-free fixed combination of Tafluprost 0.0015% and Timolol 0.5% administered once at night (8pm) in POAG or OHT patients suffering from mild OSD and requiring further IOP reduction while in topical treatment with BAK-preserved Latanoprost 0.05 mg/ml. Three Italian recruiting centers are included in the study and the estimated number of patients to be enrolled is 43. After evaluating the patient's eligibility, the patients will suspend the treatment with latanoprost and will be administered one eye drop of tafluprost/timolol fixed combination at 20:00 (+/- 1 hour) at the end of the V1B visit. Active drug will be contained (about 30 µl, one drop) contains about 0.45 micrograms of tafluprost and 0.15 mg of timolol. The Study consists in 6 Visits: 1. Screening visit V0 and baseline V1A. 2. Treatment period visit V1B; V2; V3A; V3B. 3. End of study V3B.

Conditions

• Glaucoma, Open-Angle
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	tafluprost/timolol	One ml active drug contains: 15 micrograms of tafluprost and 5 mg of timolol (as maleate). A single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost and 1.5 mg of timolol. One drop (about 30 µl) contains about 0.45 micrograms of tafluprost and 0.15 mg of timolol. Patients will be administrered with one drop in the conjunctival sac of the affected eye (s) once a day.

Timeline

• Start date: 2020-06-04
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2022-03-29
• Last updated: 2022-03-29

Locations

3 sites across 1 country: Italy